NCT04679558

Brief Summary

This study ia conducted to know the antibacterial effect of chlorhexidine on the mouth flora speciallly in adolescent special needs who can't hold the tooth brush properly

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Sep 2020

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 22, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2021

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2021

Completed
Last Updated

August 13, 2021

Status Verified

August 1, 2021

Enrollment Period

10 months

First QC Date

December 14, 2020

Last Update Submit

August 11, 2021

Conditions

Caries

Outcome Measures

Primary Outcomes (1)

  • Streptococcus mutans count

    Antibacterial effect of chlorhexidine on streptococcus mutans count

    1 year

Study Arms (2)

Comparator

ACTIVE COMPARATOR

Preventive protocol

Behavioral: Preventive protocol

Intervention

EXPERIMENTAL

Adding chlorhexidine to the preventive protocol

Drug: Chlorhexidine varnish added to the preventive protocol

Interventions

Chlorhexidine varnish added to the preventive protocolDRUG

Antibacterial agent varnish added to the preventive protocol

Also known as: Varnish
Intervention
Preventive protocolBEHAVIORAL

Preventive protocol

Also known as: Caries preventive protocol
Comparator

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • clinical diagnosis of disability like special needs autism and down syndrome

You may not qualify if:

  • age below 13

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School

Giza, Egypt

Location

MeSH Terms

Interventions

Paint

Intervention Hierarchy (Ancestors)

Manufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Katreen Fouad

    Resident

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

December 14, 2020

First Posted

December 22, 2020

Study Start

September 15, 2020

Primary Completion

July 15, 2021

Study Completion

August 11, 2021

Last Updated

August 13, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will share

Journal

Shared Documents
STUDY PROTOCOL
Time Frame
10 months
Access Criteria
Journal article

Locations

EG(1)